Kornimate/medical-research-clean huggingface dataset:
use of recombinant hcg to prevent breast cancer in brca1 and brca2 carriers

Conditions: hCG; BRCA1 Mutation; BRCA2 Mutation

Summary: specific aim: to establish the proof of principle that treatment of "high breast cancer risk" women with recombinant human chorionic gonadotropin (r-hcg) will change their breast epithelium's high risk genomic profile to one similar to that identified in women with a history of early full first term pregnancy.

this study is based on the investigators preclinical data that have demonstrated that r-hcg exerts a mammary cancer preventive effect that is mediated by the induction of gland differentiation, which results in permanent changes in the genomic signature of this organ. this exploratory study will evaluate the genomic profile of breast epithelial cells obtained from random periareolar fine needle aspiration (rpfna) specimens performed in high risk women treated for 90 days (an extra 4 weeks in a subgroup) with r-hcg. this knowledge will serve as the basis for establishing a novel genomic biomarker that will serve as a surrogate endpoint in future preventive clinical trials. the objective of the proposed study is to characterize the genomic profile of breast epithelial cells obtained from 35 asymptomatic high breast cancer risk nulliparous premenopausal women carriers of brca1 and brca2 deleterious mutations. gene expression measurements and benign breast tissue specimens will be obtained at baseline (time 0), after treatment with r-hcg at 90 days (time 1), at 270 days from baseline (time 2) and (in a subgroup) at 60 weeks (+/- 4 weeks). the primary objective of the study is to compare the gene expression profiles of these women across the three (or four) time points and identify differentially expressed genes. the investigator is interested in comparing the expression profiles between all pairs of time points as well as across time. the comparison of profiles before and after treatment with r-hcg, both at 90 and 270 days are of particular interest. the women will receive 3x/week injections of 250 microgram r-hcg for a total of 12 weeks (an extra 4 weeks in a subgroup). core needle biopsies specimens will be primarily utilized for analysis of genomic expression by cdna microarray. in addition, a series of surrogate intermediate markers such as cytomorphologic evaluation and cell proliferation index will be analyzed.

Eligibility criteria:
inclusion criteria: * premenopausal women * brca1 carrier exclusion criteria: * history of allergic reaction to compounds of similar chemical or biologic composition to hcg * receiving medication that could interfere with the study protocol objectives (hormonal contraceptives, androgens, prednisone, thyroid hormones, insulin) * previous treatment with follicle stimulating hormone for assisted reproduction * uncontrolled intercurrent illness * heart disease * severe cognitive decline * psychiatric desease * hiv positive * hepatitis b or c infection
a reversal in the vascularity of metastatic liver tumors from colorectal cancer after the cessation of anti-vegf therapy

Conditions: Colorectal Cancer

Summary: objective: to assess the effect of bevacizumab on tumor vessels, and the reversibility of the effect, using contrast-enhanced ultrasonography (ceus) and histology in patients with metastatic liver tumors derived from colorectal cancer. background data: direct evidence on the reversibility of any change in tumor vascularity upon bevacizumab cessation in the clinical setting is lacking. methods: the study included 10 patients who received chemotherapy including bevacizumab, experienced a reduction in tumor vascularity as demonstrated by ceus and consequently underwent liver resection. ceus was performed before and immediately after 4 courses of chemotherapy and one day before surgery. the number of microvessels highlighted by anti-cd34 antibody in the viable tumor tissue was counted to quantify the microvessel density (mvd). as a control, 10 surgical specimens from 10 patients who had not received chemotherapy were examined.


Eligibility criteria:
inclusion criteria: * patients who received chemotherapy (folfox) including bevacizumab. the patients had an associated reduction in tumor vascularity as estimated by ultrasonography and consequently underwent surgical resection of the metastatic liver tumors for curative purposes. exclusion criteria: * none
flixonase safety in patients with allergic rhinitis (ar)

Conditions: Rhinitis, Allergic, Perennial

Summary: this is an inception cohort study that analyses data from an administrative medical records database. the two inception cohorts are: 1) patients initiated on intranasal fp and 2) patients initiated on another ins (not fp). the candidates for the inception cohorts did not use any intranasal steroid in the year prior to initiation.


Eligibility criteria:
inclusion criteria: * patient records dated between january 1990 - january 2002 were used to develop the overall study cohort. the cohort was composed of the following patients: 1. all patients with at least one prescription for flixonase 2. a random sample of patients having at least one prescription for an ins other than flixonase exclusion criteria: patient-level exclusion * patients with less than 180 days of continuous eligibility before index date * patients who are under four years of age at index date * patients who are older than 85 years of age at index date episode-level exclusion -when patient history was divided into flixonase or other ins use episodes, patients with less than 120 days of eligibility after the last prescription in the episode patients with an event of interest 180 days prior to patients' entry into the cohort or anytime prior to an episode index date were automatically excluded from the analysis of that event. this exclusion criterion was applied to rule out prevalent conditions.

Keywords: intranasal steroids beclometasone diproprionate steroid-related outcomes
the influence of hormone replacement therapy and supervised exercise training on body composition, cardiovascular risk and insulin sensitivity in postmenopausal women

Conditions: Postmenopause

Summary: this trial investigates whether supervised training in combination with hormonal substitution therapy has an impact on body composition, cardiovascular risk, risk for dementia, osteoporosis and insulin sensitivity in postmenopausal women.

270 postmenopausal women will be included. each woman will perform a 12 to 24 weeks sports program with supervised training exercises.

Eligibility criteria:
inclusion criteria: * postmenopausal women * good general health * bmi: 20-30 kg/m2 * only the use of cholesterol-, blood pressure- or/and thyroid-regulating medication is permitted exclusion criteria: * women who are not yet in the menopause * bmi \ 30 kg/m2 * use of any other medication than cholesterol-, blood pressure- and thyroid-regulating medication
comparative effectiveness of family dsmes and standard dsmes among diverse populations

Conditions: Diabetes Mellitus, Type 2

Summary: the investigators will conduct a fully-powered, comparative effectiveness randomized controlled trial that includes up to 600 patients with type 2 diabetes (t2d) and 600 of their family members. patients with t2d will be randomly assigned to either the family-dsmes arm or the standard-dsmes arm, with 300 patients in each arm. in the family-dsmes arm, one of each patient's family members will take part in the educational sessions (family members defined below). baseline and follow-up data (immediate post-intervention, 6 months post-intervention, and 12 months post-intervention) will be collected from patients and family members in both study arms. in the standard-dsmes arm, data will be collected from family members, but they will not participate in educational sessions. in both arms, the investigators will obtain a medical records release to abstract outcomes at 18 months post-intervention.


Eligibility criteria:
inclusion criteria: * adults ≥18 years of age * have t2d (hba1c ≥ 7.0) * speak english * a family member willing to take part in the study exclusion criteria: * have received formal dsme in the past three years * have a condition that makes it unlikely for them to be able to follow the protocol
metabolomic phenotyping after surgery for colon cancer: study of novel predictive biomarkers

Conditions: Colon Cancer

Summary: predictive biomarkers are needed to identify those patients with higher risk of recurrence after surgery for colon cancer with curative intent. our main objective is to determine a metabolite profile in blood plasma from patients operated from colorectal cancer that can be associated with the oncologic outcome and be validated as predictive biomarkers in future studies. a secondary objective is to study the glycolytic metabolism of colon cancer cell lines treated with plasma samples from the same patients. in particular, to validate the increased utilization of lactate by tumor cells as a metabolic substrate using postoperative human samples. patients with colorectal cancer that have undergone surgical resection will be included. plasma samples will be obtained before surgery and the 4th day and the 3rd, 6th, 12th, and 18th months after surgery. metabolic profiles in plasma samples will be determined using a kit that allows the quantification of 180 metabolites by mass spectrometry. a clinical follow up will be maintained for at least 2 years to identify tumor recurrences.

up to 30-40% of patients operated from colorectal cancer display tumor recurrence. predictive biomarkers are needed to identify those patients with higher risk of recurrence. our main objective is to determine a metabolite profile in blood plasma from patients operated from colorectal cancer that can be associated with the oncologic outcome and be validated as prognostic biomarkers in future studies. a secondary objective is to study the glycolytic metabolism of colon cancer cell lines treated with plasma samples from the same patients. in particular, to validate the increased utilization of lactate by tumor cells as a metabolic substrate using postoperative human samples, as it was previously observed by us in vitro using an inflammatory environment in conditions of hypoxia and lack of glucose. patients with colorectal cancer that have undergone surgical resection will be included. plasma samples will be obtained before surgery and the 4th day and the 3rd, 6th, 12th, and 18th months after surgery. metabolic profiles in plasma samples will be determined using a kit that allows the quantification of 180 metabolites by mass spectrometry. cellular assays will be performed on the sw620 and ht-29 colon cancer cell lines. cells will be treated with plasma samples and the concentration of lactate and other metabolites will be analyzed in the medium supernatants. a clinical follow up will be maintained for at least 2 years to identify tumor recurrences.

Eligibility criteria:
inclusion criteria: * non-metastatic colon and rectal cancer undergoing surgery with curative intent * patients signed informed consent exclusion criteria: * patients undergoing preoperative chemotherapy and/or radiotherapy * emergency surgery * surgical resection r1 or r2 * patients presenting with other known malignancies for which they are receiving treatment
inferior vena cava index in patients undergoing liver resection

Conditions: Liver Neoplasms

Summary: the aim of this study was to evaluate whether ivc index measured intraoperatively was affected by fluid administration and could add any helpful information about the hemodynamics during hepatic resection. in addition, the investigators evaluated whether ivc index was somehow correlated with the risk of postoperative complication.


Eligibility criteria:
inclusion criteria: patients who underwent hepatectomy for primary and secondary liver tumors exclusion criteria: patients with tumoral thrombosis or full tumoral involvement/compression of ivc were excluded. patients unresectable at laparotomy for any extra-hepatic or intrahepatic reason and patients previously submitted to hepatectomy were not included
peng block versus lp block for tha postop pain

Conditions: Pain, Postoperative; Hip Pain Chronic

Summary: the purpose of this randomized, double blinded, prospective study is to compare the postoperative analgesia provided by the peng block to that provided by the lpb for patients undergoing primary anterior approach tha.

regional anesthesia procedures represent a common modality for postoperative analgesia after total hip arthroplasty surgeries (tha). the standard practice many years has been the lumbar plexus block (lpb), which anesthetizes the l1-l5 lumbar nerve roots1. while the lpb offers analgesia from the associated sensory block, it also blocks motor fibers, leading to lower extremity weakness that could potentially delay the patient's ability to participate in early physical therapy and may thereby delay discharge. in the past several years, newer regional anesthesia block approaches have been described and investigated in an attempt to provide patients with postoperative analgesia while avoiding associated muscle weakness, facilitating earlier physical therapy participation and discharge. one such nerve block is the peri-capsular nerve group (peng) block, which anesthetizes the articular branches of the femoral, obturator, and accessory obturator nerves providing sensory innervation to the hip joint capsule without consistently causing lower extremity weakness2. some institutions are utilizing the peng block to provide postoperative analgesia and facilitate early mobilization. there are currently no prospective studies that directly compare the efficacy of lpb to peng block for providing postoperative analgesia after tha.

Eligibility criteria:
inclusion criteria: * elective primary total hip arthroplasty surgery anterior approach * provided informed consent * no contraindications to medications used in providing the analgesic blocks exclusion criteria: * contraindications to regional anesthesia, such as an allergy to amide local anesthetics * pre-existing coagulopathy or thrombocytopenia \<100,000 * refusal of analgesic block for pain management * presence of an progressive lower extremity neurological deficit * localized or systemic infection * chronic use of high dose opioid analgesics (defined as daily use greater than 60 mg oxycodone equivalents) * pregnant * refusal of consent
role of peanuts in healthy weight gain in athletic individuals

Conditions: Weight Gain

Summary: many athletes and military personnel desire weight gain primarily as lean mass to improve performance and effectiveness in military/sport endeavors. while much is known about the energy restriction required to reduce body weight, very little is understood about energy and macronutrients needed to promote healthy gains in body weight and lean mass. typically, athletes are encouraged to increase calorie intake by \~500 kcal/day with an emphasis on adequate protein and carbohydrate, and judicious inclusion of healthy fat-containing calorically-dense foods, including peanuts and peanut butter. this study proposes to evaluate the effect of a 10-week diet and exercise regimen designed to promote healthy weight gain. this will include increasing energy intake by 500 additional kcal/day (above weight maintenance diet) through daily provision of either peanut-based whole foods/snacks (peanut group) or a similar, high-carbohydrate, peanut-free snack (control group) along with a supervised strength training regimen. results will serve as an important first step in helping understand the gaps in knowledge related to healthy weight gain, designing better weight gain meal plans, not only in athletes and military personnel, but also in clinical populations where promotion of weight gain is advocated.


Eligibility criteria:
inclusion criteria: * interested in gaining 5 pounds of body weight to enhance effectiveness in sport, fitness, or military training/competition. * willing to eat 500 kcal/d and weight train 3x/wk for 10 weeks * have weight trained in the past 12 months * not taking medications or dietary supplements that influence study results * non-smoker * without any major medical problems (including high blood pressure or coronary heart disease) exclusion criteria: * nut, peanut, tree nut or legume allergy * no weight training experience * orthopedic limitations that affect ability to weight train * currently taking dietary supplements or prescribed pharmacological agents that may affect lean tissue accretion * current or past anabolic steroid use * have a history of or current signs of disordered eating * pregnant * abnormal levels of thyroid stimulating hormone or hemoglobin, serum lipids (e.g., fasting triglycerides \>150 mg/dl and/or total cholesterol \>200 mg/dl)

Keywords: hypercaloric diet weight training lean mass body composition
ammonia n-13 myocardial blood flow absolute quantification by pet in patients with known or suspected cad (ammonia map)

Conditions: Myocardial Ischemia; Coronary Disease; Coronary Artery Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Summary: this study is being conducted to provide access to and collect test data for an established nuclear medicine diagnostic imaging test called positron emission tomography (pet), using a specific radioactive drug called ammonia n-13 (ammonia), referred to simply as an ammonia pet scan, which is used to visualize the blood flow through the blood vessels and into the heart muscle in order to identify areas of restricted blood flow within the heart. the scanner used in this study may be a stand-alone pet scanner or a pet/ct scanner, which combines the pet scanner and a computed tomography (ct) scanner into a single device. unless otherwise stated in this consent form, the term pet will be used to refer to both stand-alone pet and pet/ct scanners. while physicians have used the ammonia pet test for many years to visualize (image) the blood flow into the heart muscle (perfusion), it is now possible to also measure the flow of blood into the heart muscle. research studies have demonstrated clinical value in reviewing the measured blood flow values in addition to reviewing the perfusion images of blood flow into the heart muscle. therefore, this study will establish a database of a large number of ammonia pet measured blood flow values to serve as a future reference.

this is a prospective, multicenter database that will be populated by sites utilizing n-13 ammonia and sponsored by ionetix. each site with access to n-13 produced under an investigational new drug (ind) application will be eligible to participate. once the site is activated, the site will enroll patients into the database that are scheduled for clinically indicated pet-mpi with n-13 (as determined by their treating physicians). pet-mpi perfusion, mbf, percent ischemia, pharmacologic stress agent, and gated left ventricular ejection fraction/function values will be collected when available, in an anonymous fashion and uploaded into the database. all patient health identifiers (phi) will be removed prior to upload. no procedures additional to those clinically indicated will be performed for the purposes of this study.

Eligibility criteria:
inclusion criteria: adults ≥18 able to give informed consent. clinical indication for pet-mpi as determined by the subject's treating physician exclusion criteria: any clinical contraindication for pharmacologic stress testing per asnc/snmmi/acc myocardial perfusion imaging guidelines when stress perfusion imaging is required clinically. inability or unwilling to give informed consent pregnant subjects

Keywords: ammonia n-13 positron emission tomography myocardial blood flow mbf myocardial perfusion ammonia n 13 injection, usp coronary artery disease
videoscopic ilioinguinal lymphadenectomy for melanoma

Conditions: Melanoma; Secondary Malignant Neoplasm of Lymph Node

Summary: groin lymph node dissection for melanoma patients is burdened by high post-operative morbidity, mainly related to wound. this is a prospective pilot trial investigated feasibility and postoperative outcomes of videoscopic ilioinguinal lymphadenectomy in patients with inguinal lymph node melanoma metastases.

videoscopic ilioinguinal dissection is a two-stage procedure. dissection is performed using an ultrasound dissector. the inguinal step is performed via three ports (one 3-5 cm above the apex of the femoral triangle, a second 5 cm medial to the adductors, and the third 5 cm lateral to the sartorius muscle). after subcutaneous inflation, a formal inguinal lymph node (ln) dissection is performed, removing the contents of the femoral triangle, with incision and removal of the femoral fascia and proximal and distal ligation of the saphenous vein with vascular endostaplers and endoclips. the specimen is extracted using an endobag from the incision of slnb, which is systematically removed, or through a small enlargement of the incision of the apex trocar for patients with clinically positive lns. the iliac step starts with open insertion in the pro-peritoneal space of a hasson trocar, followed by positioning of two additional trocars (5 and 10 mm respectively) just laterally of the umbilical pubic line. after creation of pneumo-pelvis, the iliac femoral vessels are identified, isolated and all the external iliac lns removed. afterwards, the obturator lns are dissected off the obturator nerve. lns are retrieved with an endobag or directly through the 10mm trocar after insertion of protective endotrocar. two drains are positioned at the end of procedure in the obturator fossa and in the inguinal space, respectively. intra-operative and early post-operative outcome (lenght of stay, complications, number of lns) is recorded. follow-up consists in detection of any recurrence, measurement of lymphedema of the leg and evaluation of quality of life

Eligibility criteria:
inclusion criteria: melanoma patients without distant metastasis and either positive slnb or clinically positive inguinal lymph nodes exclusion criteria: american society of anaesthesiologists (asa) classification iii-iv severe chronic obstructive pulmonary disease (copd) and other restrictive lung disease, severe ischemic heart disease and chronic heart failure previous cerebral abnormalities (aneurysm/arteriovenous malformations, ischemic/hemorrhagic stroke, primary or secondary tumors), history of deep vein thrombosis (dvt) childbearing state severe hip functional limitation previous hip/knee arthroplasty. previous surgery in the groin region (e.g., hernia repair, great saphenous vein surgery, iliac-femoral bypass) was considered a contraindication only for the iliac stage of lymphadenectomy.

Keywords: videoassisted surgery